Clinical Trial: Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Outcome After Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort

Brief Summary:

Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months after arthroscopic surgery for FAI and compare the results to people without hip problems.

Methods/design: Sixty patients with FAI and 30 persons without hip problems will be included. Pre- and postoperatively, patients will be evaluated by CT-scans. All participants will have their hip flexor and extensor muscle strength assessed and have performed kinetic and kinematic analyses of daily activities with 3D motion capture. Further, self-reported questionnaires on hip related pain, quality of life and sports activities will be collected. Finally, participants will have their daily physical activity monitored with tri-axial accelerometers for five consecutive days.

Perspectives: With this prospective cohort study the outcome of arthroscopic treatment of FAI within one year after surgery will be evaluated. If the patients fail to reach reference values one year after surgery, altered surgical procedures or rehabilitation programs to optimize treatment for the patients may be explored in future studies. Further, the investigators expect to perform long-term follow up to evaluate reoperations, conversions to total hip arthroplasty and development of osteoarthritis for the patients surgically treated for FAI.

Detailed Summary:

Introduction Femoral acetabular impingement (FAI) is caused by an abnormality in the acetabular shape or orientation (Pincer-type) by a shape abnormality in the proximal femur (Cam-type) or by a mix of the two conditions. FAI causes repeated minor damage to the labrum and edge of the acetabulum. The damage to the joint is proposed to lead to early osteoarthritis (OA) of the hip, but whether FAI is a cause or result of OA is discussed. Surgery can reduce symptoms caused by Cam or Pincer impingement and may prevent future damage to the hip joint. However, different surgical techniques are used, and only few long-term studies of the surgery exist. The latest reviews conclude that 1) the effectiveness of the surgery is not clear, 2) it is not clear how surgery affects functional performance for the patients and 3) it is unknown how surgery for FAI affects the patients in a long-term perspective.

Material and methods

Patients:

Inclusion criteria

• Planned hip arthroscopic treatment at Horsens Regional Hospital by Consultant Bent Lund
• A diagnosis of CAM and/or pincer impingement
• For patients with Cam, an alpha angle > 55 degrees on an anterior/posterior (AP) standing radiograph
• For patients with Pincer a center edge angle > 25 degrees on an AP radiograph
• No signs of retroversion in the lower 2/3 of the hip joint on an AP radiograph
• No posterior wall sign on an AP radiograph
• Osteoarthritis grade 0-1 according to Tönnis' classification
• Lateral Joint sp
  Sponsor: University of Aarhus
  

  Current Primary Outcome:

  • Hip and pelvis kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and drop jump [ Time Frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery ]
    Hip and pelvis kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol
  • Hip extensor and flexor maximal muscle strength during isometric and isokinetic contractions [ Time Frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery ]
    Hip extensor and flexor maximal strength is measured with an isokinetic dynamometer using a standardized protocol
  • Objectively measured daily physical activities during five days [ Time Frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery ]
    Physical activity is measured with a tri-axial accelerometer during a period of 5 days on the following categories: rest, standing, walking, sit to stand, cycling and high impact activity.
  • Hip-related self-reported health [ Time Frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery ]
    Hip related health is measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with hip and groin pain
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Knee and trunk kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand drop jump [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
    Knee and trunk kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol
  • Hip extensor and flexor rate of force development during isometric contraction [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
    Hip extensor and flexor rate of force development is measured with an isokinetic dynamometer using a standardized protocol
  • Self-selected walking speed [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
  • Presence of intra-articular pathology examined with FABER and impingement tests [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
  • Visual analog scale, pain [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
    Pain is measured during rest and activity with a visual analog scale. Further patients will report their pain at a visual analog scale during all physical performance tests
  • Patient expectations [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery ]
    The question, "what changes in the following items do you expect to experience as a result of the operation? (not your hopes and wishes, but realistic expectations!)" will be asked in relation to each of six items: hip pain, walking capacity, independence in everyday activities, ability to do sport, engaging in social contacts, mental well-being. The response options will be: much better, better, somewhat better, unchanged, worse, "I don't know". After surgery, the same response options will be given together with the question: "what changes in the following items have occurred as a result of the operation?" (Adapted from Mannion et al. (1))
  • Reasons for choosing surgery [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
  • Patient global treatment outcome [ Time Frame: Six month and one year after surgery ]
    The question: "How much did the operation help your hip problem?" will be asked together with the options: helped a lot, helped, helped only little, didn't help, made things worse. Adapted from Mannion et al. (1)
  • Patient-acceptable symptom state [ Time Frame: Six month and one year after surgery ]
    The question "How would you describe the result of your operation?" will be asked. There will be 5 response options: "Excellent", "Very good", "Good", "Fair", and "Poor". Adapted from Paulsen et al. (3)
  • EQ5D-Visual analog scale [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery ]
    Overall health will be evaluated with the EQ5D- Visual analog scale
  • Failure [ Time Frame: One year after surgery ]
    The surgical treatment and rehabilitation will be considered a failure if the patient have received a total hip arthroplasty
  • Re-operations and injections during the first year after surgery [ Time Frame: 3 month, 6 month, 9 month and one year after surgery ]
  • Self-reported present sports activities [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery ]
  • Time spend at preferred sports activity [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery ]
  • Sports activities during childhood (age < 18) [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
  • Time spend at sports activities during childhood [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
  • Education [ Time Frame: Preoperatively (Approx. i the time frame 0-10 weeks before surgery) ]
  • Employment [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
  • Smoking habits [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery ]
  • Alcohol intake [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year afte
    
    

    Original Secondary Outcome:

    • Knee and trunk kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand drop jump [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
      Knee and trunk kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol
    • Hip extensor and flexor rate of force development during isometric contraction [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
      Hip extensor and flexor rate of force development is measured with an isokinetic dynamometer using a standardized protocol
    • Self-selected walking speed [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
    • Presence of intra-articular pathology examined with FABER and impingement tests [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
    • Visual analog scale, pain [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery ]
      Pain is measured during rest and activity with a visual analog scale. Further patients will report their pain at a visual analog scale during all physical performance tests
    • Patient expectations [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery ]
      The question, "what changes in the following items do you expect to experience as a result of the operation? (not your hopes and wishes, but realistic expectations!)" will be asked in relation to each of six items: hip pain, walking capacity, independence in everyday activities, ability to do sport, engaging in social contacts, mental well-being. The response options will be: much better, better, somewhat better, unchanged, worse, "I don't know". After surgery, the same response options will be given together with the question: "what changes in the following items have occurred as a result of the operation?" (Adapted from Mannion et al. (1))
    • Reasons for choosing surgery [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
    • Patient global treatment outcome [ Time Frame: Six month and one year after surgery ]
      The question: "How much did the operation help your hip problem?" will be asked together with the options: helped a lot, helped, helped only little, didn't help, made things worse. Adapted from Mannion et al. (1)
    • Patient-acceptable symptom state [ Time Frame: Six month and one year after surgery ]
      The question "How would you describe the result of your operation?" will be asked. There will be 5 response options: "Excellent", "Very good", "Good", "Fair", and "Poor". Adapted from Paulsen et al. (3)
    • EQ5D-Visual analog scale [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery ]
      Overall health will be evaluated with the EQ5D- Visual analog scale
    • Failure [ Time Frame: One year after surgery ]
      The surgical treatment and rehabilitation will be considered a failure if the patient have received a total hip arthroplasty or if the HAGOS pain subscale is rated below 50 points at one year follow up. The 50 points indicates moderate pain (or worse) and weakly (or more often) pain.
    • Re-operations and injections during the first year after surgery [ Time Frame: 3 month, 6 month, 9 month and one year after surgery ]
    • Self-reported present sports activities [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery ]
    • Time spend at preferred sports activity [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery ]
    • Sports activities during childhood (age < 18) [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
    • Time spend at sports activities during childhood [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
    • Education [ Time Frame: Preoperatively (Approx. i the time frame 0-10 weeks before surgery) ]
    • Employment [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) ]
    • Smoking habits [ Time Frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery ]
      Information By: University of Aarhus
      

      Dates:
      Date Received: November 21, 2014
      Date Started: December 2014
      Date Completion: December 2017
      Last Updated: June 14, 2016
      Last Verified: June 2016